Surgical Implant Devices and Methods for Their Manufacture and Use

ABSTRACT

Sealable and repositionable implant devices are provided with one or more improvements that increase the ability of implants such as endovascular grafts to be precisely deployed or re-deployed, with better in situ accommodation to the local anatomy of the targeted recipient anatomic site, and/or with the ability for post-deployment adjustment to accommodate anatomic changes that might compromise the efficacy of the implant. A surgical implant includes an implant body and a selectively adjustable assembly attached to the implant body, having adjustable elements, and operable to cause a configuration change in a portion of the implant body and, thereby, permit implantation of the implant body within an anatomic orifice to effect a seal therein under normal physiological conditions.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application:

-   -   claims the priority, under 35 U.S.C. §119, of copending U.S.        Provisional Patent Application No. 61/428,114, filed Dec. 29,        2010;    -   is a continuation-in-part of co-pending U.S. patent application        Ser. No. 11/888,009, filed Jul. 31, 2007, which application        claims priority to U.S. Provisional Patent Application Nos.        61/078798 and 61/079100, filed Jul. 8, 2008; and    -   is a continuation-in-part of co-pending U.S. patent application        Ser. No. 12/822,291, filed Jun. 24, 2010, which application        claims priority to U.S. Provisional Patent Application No.        61/222,646, filed Jul. 2, 2009,        the prior applications are herewith incorporated by reference        herein in their entireties.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

FIELD OF THE INVENTION

The present invention relates to the field of surgical implant devicesand methods for their manufacture and use. Among the exemplaryembodiments of the present invention are improvements in sealing andretention medical devices particularly applicable to vascular surgeryand the treatment of aneurysms or other luminal defects in otheranatomic conduits, such as sealing and retention of replacement heartvalves.

BACKGROUND OF THE INVENTION

Medical and surgical implants are placed often in anatomic spaces whereit is desirable for the implant to conform to the unique anatomy of thetargeted anatomic space and secure a seal therein, preferably withoutdisturbing or distorting the unique anatomy of that targeted anatomicspace.

While the lumens of most hollow anatomic spaces are ideally circular, infact, the cross-sectional configurations of most anatomic spaces are, atbest, ovoid, and may be highly irregular. Such luminal irregularity maybe due to anatomic variations and/or to pathologic conditions that maychange the shape and topography of the lumen and its associated anatomicwall. Examples of anatomic spaces where such implants may be deployedinclude, but are not limited to, blood vessels, the heart, othervascular structures, vascular defects (such as thoracic and abdominalaortic aneurysms), the trachea, the oropharynx, the esophagus, thestomach, the duodenum, the ileum, the jejunum, the colon, the rectum,ureters, urethras, fallopian tubes, biliary ducts, pancreatic ducts, orother anatomic structures containing a lumen used for the transport ofgases, blood, or other liquids or liquid suspensions within a mammalianbody.

For a patient to be a candidate for existing endograft methods andtechnologies, to permit an adequate seal, a proximal neck of, ideally,at least 12 mm of normal aorta must exist downstream of the leftsubclavian artery for thoracic aortic aneurysms or between the origin ofthe most inferior renal artery and the origin of the aneurysm in thecase of abdominal aneurysms. Similarly, ideally, at least 12 mm ofnormal vessel must exist distal to the distal extent of the aneurysm foran adequate seal to be achieved.

Migration of existing endografts has also been a significant clinicalproblem, potentially causing leakage and profusion of aneurysms and/orcompromising necessary vascular supplies to arteries such as thecarotid, subclavian, renal, or internal iliac vessels. This problem onlyhas been addressed partially by some existing endograft designs, inwhich barbs or hooks have been incorporated to help retain the endograftat its intended site. However, most existing endograft designs aresolely dependent on radial force applied by varying length of stentmaterial to secure a seal against the recipient vessel walls.

Because of the limitations imposed by existing vascular endograftdevices and endovascular techniques, a significant number of abdominaland thoracic aneurysms repaired in the U.S. are still managed thoughopen vascular surgery, instead of the lower morbidity of theendovascular approach.

Pre-sizing is required currently in all prior art endografts. Suchpre-sizing based on CAT-scan measurements is a significant problem. Thisleads, many times, to mis-sized grafts. In such situations, more graftssegments are required to be placed, can require emergency open surgery,and can lead to an unstable seal and/or migration. Currently thereexists no endograft that can be fully repositioned after deployment.

Thus, a need exists to overcome the problems with the prior art systems,designs, and processes as discussed above.

SUMMARY OF THE INVENTION

The invention provides surgical implant devices and methods for theirmanufacture and use that overcome the hereinafore-mentioneddisadvantages of the heretofore-known devices and methods of thisgeneral type and that provide such features with improvements thatincrease the ability of such an implant to be precisely positioned andsealed, with better in situ accommodation to the local anatomy of thetargeted anatomic site. The invention provide an adjustment tool thatcan remotely actuate an adjustment member(s) that causes a configurationchange of a portion(s) of an implant, which configuration changeincludes but is not limited to diameter, perimeter, shape, and/orgeometry or a combination of these, to create a seal and provideretention of an implant to a specific area of a target vessel orstructure.

One exemplary aspect of the present invention is directed towards noveldesigns for endovascular implant grafts, and methods for their use forthe treatment of aortic aneurysms and other structural vascular defects.An endograft system for placement in an anatomic structure or bloodvessel is disclosed in which an endograft implant comprises, forexample, a non-elastic tubular implant body with at least anaccommodating proximal end. Accommodating, as used herein, is theability to vary a configuration in one or more ways, which can includeelasticity, expansion, contraction, and changes in geometry. Both oreither of the proximal and distal ends in an implant according to thepresent invention further comprise one or more circumferentialexpandable sealable collars and one or more expandable sealing devices,capable of being expanded upon deployment to achieve the desired sealbetween the collar and the vessel's inner wall. Exemplary embodiments ofsuch devices can be found in co-pending U.S. patent application Ser. No.11/888,009, filed Jul. 31, 2007, and Ser. No. 12/822,291, filed Jun. 24,2010, which applications have been incorporated herein in theirentireties. Further embodiments of endovascular implants according tothe present invention may be provided with retractable retention tinesor other retention devices allowing an implant to be repositioned beforefinal deployment. In other embodiments, the implant can be repositionedafter final deployment. An endograft system according to the presentinvention further comprises a delivery catheter with an operable tubularsheath capable of housing a folded or compressed endograft implant priorto deployment and capable of retracting or otherwise opening in at leastits proximal end to allow implant deployment. The sheath is sized andconfigured to allow its placement via a peripheral arteriotomy site, andis of appropriate length to allow its advancement into the aortic valveannulus, ascending aorta, aortic arch, and thoracic or abdominal aorta,as required for a specific application.

While some post-implantation remodeling of the aortic neck proximal toan endovascular graft (endograft) has been reported, existing endografttechnology does not allow for the management of this condition withoutplacement of an additional endograft sleeve to cover the remodeledsegment.

Exemplary endografts of the present invention as described herein allowfor better accommodation by the implant of the local anatomy, using aself-expandable or compressible gasket for the sealing interface betweenthe endograft collar and the recipient vessel's inner wall. Furthermore,exemplary endografts of the present invention as disclosed herein areprovided with a controllably releasable disconnect mechanism that allowsremote removal of an adjustment tool and locking of the retainedsealable mechanism after satisfactory positioning and sealing of theendograft. In some exemplary embodiments according to the presentinvention, the controllably releasable disconnect mechanism may beprovided in a manner that allows post-implantation re-docking of anadjustment member to permit post-implantation repositioning and/orresealing of an endograft subsequent to its initial deployment.

In other exemplary applications encompassed by the present invention,improved devices for sealing other medical devices such as vascularcannulae may be provided. The present invention further includes noveldesigns for vascular cannulae to be used when bi-caval cannulation ofthe heart is indicated, eliminating the need to perform circumferentialcaval dissection and further reducing the tissue trauma caused by priorart balloon or other bypass cannulae. While the vascular cannulae of thepresent invention are inserted and positioned by a surgeon in thestandard fashion, the need for circumferential dissection of the cavaeand tourniquet placement is obviated. After the vascular cannulae of thepresent invention are positioned and secured with purse string sutures,the surgeon deploys the adjustable sealing devices of the cannulae byturning an adjustment tool or torque wire. Once the sealing devices aredeployed, all of the venous return is diverted. The sealing devicesdeploy around the distal ends of the cannulae and allow blood to flowthrough the lumen of the cannulae, but not around the sealing devices.Use of these cannulae minimizes the chance of caval injury byeliminating the need for circumferential dissection. Additionally, theconfiguration of the adjustable sealing device in relation to thecannula is such that the adjustable sealing device is “flush” with thecannula so that no acute change in diameter exists along the externalsurface of the cannula, which serves to avoid tissue trauma duringinsertion and withdrawal into and out of bodily structures.

The present invention addresses several major problems presented byexisting designs for balloon cannulae. In various exemplary embodimentsaccording to the present invention, the lumens are configured such thata cannula with an adjustable sealing device can be deployed withoutcompromising either the flow within the principle lumen of the cannulaor the seal between the cannula and the structure within which thecannula lies. Moreover, a disclosed example of a cannula according tothe present invention is provided with a trough within the cannula bodyat its distal end in which the adjustable sealing device member liessuch that, when undeployed during insertion and withdrawal, there is asmooth interface between the external cannula wall and the undeployedsealing device, allowing for smoother, easier, and safer insertion andwithdrawal.

Moreover, existing designs for balloon cannulae are unable to provide atruly symmetrical placement of an inflated balloon around a centrallumen of standard diameter. The asymmetry that results with conventionalballoon inflation is sufficient to displace the lumen from the truecenter of the endovascular lumen in which the balloon cannula is placed,resulting in unpredictable and suboptimal flow characteristicstherethrough. The altered hemodynamics of such flow with an existingballoon cannula increases the likelihood of intimal vascular injury andclot or plaque embolization. Vascular cannulae of the present inventionachieve the surprising result of having the flow characteristics of anon-balloon cannula by maintaining the preferred laminar flowcharacteristics of a circular main lumen of consistent diameter,positioned and maintained in or near the center of vascular flow by anadjustable sealing device originally provided within a recessed troughin the exterior wall of the cannula, with accessory lumens containedwithin an externally circular cannular wall. This allows for betterseal, less vascular trauma, and easier vascular ingress and egress.

In addition, vascular cannulae according to the present invention may beprovided with retractable stabilizing elements to anchor the inflatedballoon within a vessel lumen during use. Such stabilizing elementsfurther make use of the trough within the cannula body, with thestabilizing elements retracting into this trough during insertion andremoval, allowing for smooth and trauma-free entry and egress of thecannula.

Certain aspects of the present invention are directed towards noveldesigns for sealable endovascular implant grafts, and methods for theiruse for the treatment of aortic aneurysms and other structural vasculardefects or for heart valve replacements. Various embodiments ascontemplated within the present invention may include any combination ofexemplary elements as disclosed herein or in the co-pending patentapplications referenced above.

In an exemplary embodiment according to the present invention, asealable vascular endograft system for placement in a vascular defect isprovided, comprising an elongated main implant delivery catheter with anexternal end and an internal end for placement in a blood vessel withinternal walls. In such an exemplary embodiment, the main implantdelivery catheter further comprises a main implant delivery cathetersheath that may be openable or removable at the internal end and a mainimplant delivery catheter lumen containing within a compressed or foldedendovascular implant. Further, in such an exemplary embodiment, anendovascular implant comprises a non-elastic tubular implant body withan accommodating proximal end terminating in a proximal sealablecircumferential collar that may be expanded by the operator to achieve afluid-tight seal between the proximal sealable circumferential collarand the internal walls of the blood vessel proximal to the vasculardefect. Moreover, in such an exemplary embodiment, an endovascularimplant may further comprises a non-elastic tubular implant body with anaccommodating distal end terminating in a distal sealablecircumferential collar controlled by a distal variable sealing device,which may be expanded by the operator to achieve a fluid-tight sealbetween the distal sealable circumferential collar and the internalwalls of the blood vessel distal to the vascular defect.

In a further exemplary embodiment according to the present invention, animplant interface is provided for a sealable attachment of an implant toa wall within the lumen of a blood vessel or other anatomic conduit.

In a yet further exemplary embodiment according to the presentinvention, an implant gasket interface is provided for a sealableattachment of an implant to a wall within the lumen of a blood vessel orother anatomic conduit, wherein the sealable attachment provides forauto-adjustment of the seal while maintaining wall attachment toaccommodate post-implantation wall remodeling.

Still other exemplary embodiments of endografts and endograft deliverysystems according to the present invention serve as universal endograftcuffs, being first placed to offer their advantageous anatomicaccommodation capabilities, and then serving as a recipient vessel forother endografts, including conventional endografts.

Furthermore, exemplary embodiments of endografts and endograft deliverysystems according to the present invention may be provided with amechanism to permit transfer of torque or other energy from a remoteoperator to an adjustment member comprising a sealable, adjustablecircumferential assembly controlled by an adjustment tool, which may bedetachable therefrom and may further cause the assembly to lock upondetachment of the tool. In some exemplary embodiments of the presentinvention, the variable sealing device may be provided with a re-dockingelement that may be recaptured by subsequent operator interaction,allowing redocking and repositioning and/or resealing of the endograftat a time after its initial deployment.

Moreover, the various exemplary embodiments of the present invention asdisclosed herein may constitute complete endograft systems, or they maybe used as components of a universal endograft system as disclosed inco-pending patent applications that may allow the benefits of thepresent invention to be combined with the ability to receive otherendografts.

Finally, the present invention encompasses sealable devices that may beused in other medical devices such as adjustable vascular cannulas orother medical or surgical devices or implants, such as aortic valves.

With the foregoing and other objects in view, there is provided, inaccordance with the invention, a surgical implant including an implantbody and a selectively adjustable assembly attached to the implant body,having adjustable elements, and operable to cause a configuration changein a portion of the implant body and, thereby, permit implantation ofthe implant body within an anatomic orifice to effect a seal thereinunder normal physiological conditions.

The preceding description is presented only as an exemplary applicationof the devices and methods according to the present invention.

Although the invention is illustrated and described herein as embodiedin surgical implant devices and methods for their manufacture and use,it is, nevertheless, not intended to be limited to the details shownbecause various modifications and structural changes may be made thereinwithout departing from the spirit of the invention and within the scopeand range of equivalents of the claims. Additionally, well-knownelements of exemplary embodiments of the invention will not be describedin detail or will be omitted so as not to obscure the relevant detailsof the invention.

Additional advantages and other features characteristic of the presentinvention will be set forth in the detailed description that follows andmay be apparent from the detailed description or may be learned bypractice of exemplary embodiments of the invention. Still otheradvantages of the invention may be realized by any of theinstrumentalities, methods, or combinations particularly pointed out inthe claims.

Other features that are considered as characteristic for the inventionare set forth in the appended claims. As required, detailed embodimentsof the present invention are disclosed herein; however, it is to beunderstood that the disclosed embodiments are merely exemplary of theinvention, which can be embodied in various forms. Therefore, specificstructural and functional details disclosed herein are not to beinterpreted as limiting, but merely as a basis for the claims and as arepresentative basis for teaching one of ordinary skill in the art tovariously employ the present invention in virtually any appropriatelydetailed structure. Further, the terms and phrases used herein are notintended to be limiting; but rather, to provide an understandabledescription of the invention. While the specification concludes withclaims defining the features of the invention that are regarded asnovel, it is believed that the invention will be better understood froma consideration of the following description in conjunction with thedrawing figures, in which like reference numerals are carried forward.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying figures, where like reference numerals refer toidentical or functionally similar elements throughout the separateviews, which are not true to scale, and which, together with thedetailed description below, are incorporated in and form part of thespecification, serve to illustrate further various embodiments and toexplain various principles and advantages all in accordance with thepresent invention. Advantages of embodiments of the present inventionwill be apparent from the following detailed description of theexemplary embodiments thereof, which description should be considered inconjunction with the accompanying drawings in which:

FIG. 1 is a fragmentary, perspective view of an exemplary embodiment ofa proximal aspect of a selectively expandable and contractable endograftaccording to the present invention with the endograft in a relativelyexpanded form;

FIG. 2 is a fragmentary, perspective view of the selectively expandableand contractable endograft of FIG. 1 with the endograft in a relativelycontracted form;

FIG. 3 is a fragmentary, perspective view of another exemplaryembodiment of a proximal aspect of an endograft according to the presentinvention further incorporating a lattice structure;

FIG. 4A is a fragmentary, perspective view of the endograft of FIG. 3with the endograft in a relatively contracted form;

FIG. 4B is a fragmentary, perspective view of the endograft of FIG. 3with the endograft in a partially expanded form;

FIG. 4C is a fragmentary, perspective view of the endograft of FIG. 3with the endograft in a fully expanded form;

FIG. 5A is a fragmentary, partially hidden, perspective view of anexemplary embodiment of a microcylinder locking mechanism with anassociated adjustment tool prior to engagement of the microcylinderlocking mechanism by the adjustment tool;

FIG. 5B is a fragmentary, partially hidden, perspective view of themicrocylinder locking mechanism and adjustment tool of FIG. 5B withengagement of the microcylinder locking mechanism by the adjustmenttool;

FIG. 5C is a fragmentary, partially hidden, perspective view of anexemplary embodiment of the microcylinder locking mechanism andadjustment tool of FIG. 5B after adjustment and disengagement of theadjustment tool from the microcylinder locking mechanism;

FIG. 6A is an axial cross-sectional view of the microcylinder and guidebullet along section line A-A of FIG. 5A with tines captures instriations of the microcylinder;

FIG. 6B is an axial cross-sectional view of the adjustment tool alongsection line B-B of FIG. 5A;

FIG. 6C is an axial cross-sectional view of the microcylinder alongsection line C-C of FIG. 5B;

FIG. 6D is an axial cross-sectional view of the microcylinder, the guidebullet, and the tool sheath along section line D-D of FIG. 5B withoutthe adjustment member with the tines removed from the microcylinder bythe adjustment tool;

FIG. 6E is an axial cross-sectional view of another exemplary embodimentof a microcylinder locking mechanism and adjustment tool sheathaccording to the invention where the adjustment tool also has striationshaving a rectangular cross-sectional shape and has a smooth exterior;

FIG. 6F is an axial cross-sectional view of yet another exemplaryembodiment of a microcylinder locking mechanism according to theinvention in which the microcylinder has striations with a triangularcross-sectional shape and with the tines caught in the striations of themicrocylinder;

FIG. 6G is an axial cross-sectional view of the microcylinder lockingmechanism of FIG. 6F and an adjustment tool according to the inventionin which the tines are removed from the microcylinder by the adjustmenttool;

FIG. 7A is a longitudinal, partial cross-sectional view of an exemplaryembodiment of an adjustment control locking mechanism according to thepresent invention with a controllable catch mechanism disengaged;

FIG. 7B is a longitudinal, partial cross-sectional view of theadjustment control locking mechanism of FIG. 7A with the controllablecatch mechanism engaged.

FIG. 8A is a fragmentary, partially hidden, perspective view of anexemplary embodiment of a microcylinder locking mechanism according tothe invention with internal locking tines of unequal length and with anassociated adjustment tool sheath prior to engagement of themicrocylinder locking mechanism by the adjustment tool sheath;

FIG. 8B is a fragmentary, partially hidden, perspective view of themicrocylinder locking mechanism and adjustment tool sheath of FIG. 7Awith engagement of the microcylinder locking mechanism by the adjustmenttool sheath;

FIG. 8C is a fragmentary, partially hidden, perspective view of themicrocylinder locking mechanism and adjustment tool sheath of FIG. 7Bafter adjustment and disengagement of the microcylinder lockingmechanism with the adjustment tool sheath.

FIG. 9A is an axial cross-sectional view of retention tines sheathed byan expanded compressible foam gasket in an exemplary endograft accordingto the present invention with the tines in a non-extended state;

FIG. 9B is a fragmentary, perspective view of the retention tines ofFIG. 9A exposed and deployed through a compressible foam gasket by anexpanded sealable collar in an exemplary endograft according to thepresent invention;

FIG. 10A is a fragmentary, axial cross-sectional view of an exemplaryendovascular interface cuff according to the present invention, in whichthe interface cuff has been positioned over an endovascular guidewire toa desired recipient site in the aorta proximal to an aortic aneurysm sacbut has not been expanded therein;

FIG. 10B is a fragmentary, transverse cross-sectional view of theinterface cuff of FIG. 10A;

FIG. 11A is a fragmentary, axial cross-sectional view of the interfacecuff of FIG. 10A, with expansion of the endovascular interface cuff inthe aorta to achieve a seal and with retention tine engagement of theaortic wall in the desired recipient site proximal to the aorticaneurysm sac at the level of A-A′;

FIG. 11B is a fragmentary, transverse cross-sectional view of theinterface cuff of FIG. 11A;

FIG. 12 is a fragmentary, axial cross-sectional view of the interfacecuff of FIG. 10A with delivery of an endograft secured within the rigidcuff of the interface cuff;

FIG. 13 is a fragmentary, axial cross-sectional view of the interfacecuff of FIG. 12 with the guidewire removed and with the adjustment tooldetached and removed;

FIG. 14A is a fragmentary, perspective view of an exemplary embodimentof an actively controllable endograft according to the present inventionin which a latticework external to the lumen of an endograft can beradially displaced by controlled rotation of an adjustment member, thelattice structure being in a contracted state;

FIG. 14B is a fragmentary, perspective view of the actively controllableendograft of FIG. 14A in which the lattice structure is in an expandedstate;

FIG. 15A is a side perspective view of an exemplary embodiment of anadjustable vascular cannula according to the present invention;

FIG. 15B is a side perspective and partially hidden view of theadjustable vascular cannula of FIG. 15A within a recipient blood vesselwith an adjustable seal device in a non-deployed, contracted position;and

FIG. 15C is a side perspective and partially hidden view of theadjustable vascular cannula of FIG. 15B with the adjustable seal devicein a deployed, expanded position.

DETAILED DESCRIPTION OF THE INVENTION

As required, detailed embodiments of the present invention are disclosedherein; however, it is to be understood that the disclosed embodimentsare merely exemplary of the invention, which can be embodied in variousforms. Therefore, specific structural and functional details disclosedherein are not to be interpreted as limiting, but merely as a basis forthe claims and as a representative basis for teaching one skilled in theart to variously employ the present invention in virtually anyappropriately detailed structure. Further, the terms and phrases usedherein are not intended to be limiting; but rather, to provide anunderstandable description of the invention. While the specificationconcludes with claims defining the features of the invention that areregarded as novel, it is believed that the invention will be betterunderstood from a consideration of the following description inconjunction with the drawing figures, in which like reference numeralsare carried forward.

Alternate embodiments may be devised without departing from the spiritor the scope of the invention. Additionally, well-known elements ofexemplary embodiments of the invention will not be described in detailor will be omitted so as not to obscure the relevant details of theinvention.

Before the present invention is disclosed and described, it is to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only and is not intended to belimiting. The terms “a” or “an”, as used herein, are defined as one ormore than one. The term “plurality,” as used herein, is defined as twoor more than two. The term “another,” as used herein, is defined as atleast a second or more. The terms “including” and/or “having,” as usedherein, are defined as comprising (i.e., open language). The term“coupled,” as used herein, is defined as connected, although notnecessarily directly, and not necessarily mechanically.

Relational terms such as first and second, top and bottom, and the likemay be used solely to distinguish one entity or action from anotherentity or action without necessarily requiring or implying any actualsuch relationship or order between such entities or actions. The terms“comprises,” “comprising,” or any other variation thereof are intendedto cover a non-exclusive inclusion, such that a process, method,article, or apparatus that comprises a list of elements does not includeonly those elements but may include other elements not expressly listedor inherent to such process, method, article, or apparatus. An elementproceeded by “comprises . . . a” does not, without more constraints,preclude the existence of additional identical elements in the process,method, article, or apparatus that comprises the element.

As used herein, the term “about” or “approximately” applies to allnumeric values, whether or not explicitly indicated. These termsgenerally refer to a range of numbers that one of skill in the art wouldconsider equivalent to the recited values (i.e., having the samefunction or result). In many instances these terms may include numbersthat are rounded to the nearest significant figure.

Herein various embodiments of the present invention are described. Inmany of the different embodiments, features are similar. Therefore, toavoid redundancy, repetitive description of these similar features maynot be made in some circumstances. It shall be understood, however, thatdescription of a first-appearing feature applies to the later describedsimilar feature and each respective description, therefore, is to beincorporated therein without such repetition.

Described now are exemplary embodiments of the present invention.Referring now to the figures of the drawings in detail and, first,particularly to FIG. 1 thereof, there is shown a perspective view of anexemplary embodiment of the proximal aspect of a sealable endograftsystem 1000 according to the present invention, in which the endograftis in a relatively expanded form. FIG. 2 is a perspective view of theembodiment of the proximal aspect of a sealable endograft system 1000according to the present invention of FIG. 1, showing the endograft in arelatively contracted form. This exemplary endograft system 1000 has theability to be selectively expanded and contracted to a diameter selectedby the implanting physician. In general, the endograft system 1000 has,along its intermediate extent and, possibly, also at its distal portion(at the downstream end of the prosthesis), a relatively constantdiameter portion. At its proximal portion (at the upstream end of theprosthesis), the endograft system 1000 is able to impart a configurationchange to selectively adjustable portion of the implant. Features of theinventive controllable endograft system 1000 are described in furtherdetail in U.S. patent application Ser. No. 11/888,009, filed Jul. 31,2007, and Ser. No. 12/822,291, filed Jun. 24, 2010, which have beenincorporated herein and detail of which is not replicated herein for thesake of brevity.

The exemplary sealable endograft system 1000 shown in FIGS. 1 and 2comprises a hollow tubular endograft body 1005 having an accommodatingproximal cuff 1010 and an intermediate, substantially rigid, tubularmember 1015. The distal end of such an endograft (not shown in FIGS. 1and 2) may be any or all of accommodating, elastic, rigid, stent-laden,or even replicate the proximal end, depending upon the various exemplaryembodiments according to the present invention. A selectively adjustablecircumferential assembly 1020 is disposed at the proximal cuff 1010.Contained in one exemplary embodiment of the circumferential assembly1020 is a circumferential channel enclosing an adjustment member 1025(indicated only diagrammatically with a solid line). The adjustmentmember 1025 causes the expansion/contraction of the accommodatingproximal cuff 1010 by looping around the perimeter and by beinglengthened or shortened, respectively. The adjustment member 1025, forexample, interacts with a control device 1030 that is operable to causean increase or decrease in the circumference of the circumferential loop1025 by the application of rotational torque to the distal aspect of anadjustment tool 1035 emerging from the control device 1030. Theadjustment member 1025 can be integral with the adjustment tool 1035 inan exemplary embodiment of the circumferential assembly 1020, or can beremovable as shown, for example, in FIG. 10A.

Such an adjustment member 1025 may take many forms in the presentinvention. In one exemplary embodiment according to the presentinvention, the adjustment member 1025 is a micro-threaded cable that isfixed at one end to the control device 1030, which is in the form of amicrocylinder, and the adjustment tool 1035 threads through a threadedaspect of the microcylinder 1030 in order to effect a change in thecircumference of the proximal cuff 1010. A forwardly imposed torque onthe adjustment tool 1035 cause expansion of the adjustment tool 1035.Expansion of the adjustment member 1025 in its circumferential extenthas the effect of expanding the proximal aspect of the sealableendograft system 1000 to allow for precise sealing of the sealableendograft system 1000 within a recipient blood vessel such as the aorta(not shown in FIG. 1 or 2). Conversely, reverse torque on the adjustmenttool 1035 has the effect of decreasing the circumference of thecircumferential loop of the adjustment member 1025 and, thus,contracting the proximal aspect of the sealable endograft system 1000,allowing for re-positioning as needed. In FIGS. 1 and 2, the adjustmenttool 1035 may extend distally through the lumen of the sealableendograft system 1000. Alternatively, the adjustment tool 1035 mayextend distally through a separate lumen provided in the sealableendograft system 1000 (not shown in FIG. 1 or 2).

FIGS. 3 and 4A to 4C are perspective views of yet another exemplaryembodiment of a proximal aspect of a sealable endograft system 1000according to the present invention that further incorporates a stent orlattice structure 1041 (which, in another embodiment, can be acompressible foam gasket). The lattice structure 1041 is provided with alattice interruption 1045 to allow for variations in the circumferenceof the proximal aspect of the endograft. This lattice interruption 1045may take the form of a V-shape as shown in FIGS. 4B and 4C or may beotherwise configured. As in FIGS. 1 and 2, the sealable endograft system1000 of FIG. 3 also has an accommodating proximal cuff 1010 whichencloses the terminal lattice structure 1040 as shown and also enclosesan adjustment member 1025 that loops through a control device 1030 thatis provided to allow increase or decrease in the circumference of the,e.g., circumferential loop of the adjustment member 1025 by theapplication of rotational torque to the distal aspect of the adjustmenttool 1035 emerging from the control device 1030. The progression ofFIGS. 4A to 4C shows the endograft in a relatively contracted form inFIG. 4A, in a partially expanded form in FIG. 4B, and in a fullyexpanded form in FIG. 4C. As the lattice interruption 1045 is closed inFIGS. 3 and 44, it can be seen only in FIGS. 4B and 4C. One exemplaryconfiguration for the lattice interruption 1045 can be a woven materialthat is stretched in the expanded state and attached to the lattice 1041and, when allowed to reduce, the woven material resist buckling. Thisconfiguration allows the diameter to increase beyond the maximumdiameter that the graft will allow with the stent alone.

FIG. 5A shows an exemplary embodiment of the control device 1030 in theform of a microcylinder locking mechanism 1050. This locking mechanism1050 is changed from a locked state to an unlocked state by anadjustment tool 1060, which comprises a tool sheath 1062 having a keyedcollar portion 1065. The adjustment tool 1060 is fixed, in both thelongitudinal and radial extents, to the remote adjustment tool 1035. Theprogression of FIGS. 5A to 5C show how the locking mechanism 1050 ischanged from the locked state (in which adjustment of the adjustmentmember 1025 is prohibited) to the unlocked state (in which adjustment ofthe adjustment member 1025 is permitted), and, then, back to the lockedstate.

Before explaining the change between states, the configuration of anexemplary embodiment of the locking mechanism 1050 is described further.The exterior of the locking mechanism 1050 is comprised of amicrocylinder 1052 having a set of circumferentially spaced-apart,interior striations 1055. The locking mechanism 1050 is longitudinallyand rotationally fixed to the proximal cuff 1010. A guide bullet 1070 isreceived within the hollow, internally striated microcylinder 1052. Theguide bullet 1070 has a longitudinal threaded bore that received therein(in a threaded manner) the adjustment member 1025. The adjustment member1025 completely traverses the bore of the guide bullet 1070 andterminates distally of the guide bullet 1070 in a keyed block 1075 thatis rotationally fixed to the adjustment member 1025. The guide bullet1070 has at least two opposing, flexible tines 1072 that extend radiallyoutward, in a natural state that, together, has a diameter greater thanthe internal diameter of the locking microcylinder 1052 (the tines can,as well, be spring loaded outwardly). The tines 1072 have a terminalportion that is shaped to fit within a corresponding shaped of eachstriation 1055 within the microcylinder 1052. As such, when the tines1072 are compressed and the guide bullet 1070 is placed within themicrocylinder with the adjustment member 1025 threaded therewithin, thetines 1072 press outwardly against the internal surface of themicrocylinder 1052 and, when appropriately rotated therein, the tines1072 each lock within a respective opposing one of the striations 1055.In such a state, the tines 1072 both form-fittingly and force-fittinglylock within inner striations 1055 when unconstrained. If, for example,there were three tines 1072 separated by 120 degrees each, then thetines 1072 would each lock within a respective one of the striations1055 that are, also, 120 degrees apart along the interior surface of themicrocylinder 1052. The frictional force of the tines 1072 against theinside surface of the microcylinder 1052 is sufficiently strong toprevent longitudinal movement of the guide bullet 1070, even if thekeyed block 1075 is rotated unless the tines 1072 are removed from theirlocked position against the interior surface of the microcylinder. Insuch a configuration, the microcylinder 1052 and the guide bullet 1070prevent rotation of the adjustment member 1025 without, not only aparticular external force applied thereto, but also a removal of thetines 1072 from the interior surface of the microcylinder 1052.

Rotation of the adjustment member 1025, therefore, is carried out withthe adjustment tool 1060. The adjustment tool 1060 provides both theability to rotate the keyed block 1075 but also the ability to separatethe tines 1072 from the interior surface of the microcylinder 1052. Tocarry out these functions, the tool sheath 1062 has a sufficientcylindrical length to slide between the tines 1072 and the interiorsurface of the microcylinder 1052 anywhere the tines 1072 are contactingthe interior surface. As such, the longitudinal length of the toolsheath 1062 can be, but does not necessarily have to be, as long as themicrocylinder 1052. FIG. 5A shows the microcylinder 1052 with the guidebullet 1070 in a locked position, prior to interface by the remoteadjustment tool 1060. When the adjustment tool 1060 is slid into themicrocylinder 1052, as shown in the progression of FIGS. 5A to 5B, thesmooth interior surface of the tool sheath 1062 first slides along theouter surface of the tines and, then, along and past the distal ends ofthe tines 1072, at which time the tines 1072 no longer contact theinterior surface of the microcylinder 1052. The orientation of themicrocylinder locking mechanism 1050 and the adjustment tool 1060 inFIG. 5B now allows for repositioning of the adjustment member 1025 andrelocation of the guide bullet 1070 within the microcylinder 1052.

The keyed collar portion 1065 has a distal taper 1067 that reduces theouter diameter of the tool sheath 1062 inwards to such an extent that itacts as a funnel to direct the keyed block 1075 directly into the radialcenter of the keyed collar portion 1065. At the proximal-most end of thecollar portion 1065 is an internal key 1069 having an internalcircumferential shape corresponding to an external circumferential shapeof the keyed block 1075. As such, when the adjustment tool 1060 isinserted into the microcylinder 1052 and releases the tines 1072 fromthe interior surface thereof, the tool sheath 1062 can pass the tines1072 (wherever they may be inside the microcylinder 1052) sufficientlyfar to permit the keyed block 1075 to slide along the interior distaltaper 1067 and press against the internal bore of the key 1069. Withslight rotation either way of the adjustment tool 1060 (by rotation ofthe adjustment tool 1035), the keyed block 1075 will fall into theinternal bore of the key 1069 in a form-fit, thereby enabling rotationof the adjustment member 1025 (via keyed block 1075) in a correspondingmanner to any rotation of the adjustment tool 1035 by a user.

The locking mechanism 1050 is longitudinally and rotationally fixed tothe circumferential assembly 1020 such that rotation of the lockingmechanism 1050 in a first direction causes a contraction of thecircumferential assembly 1020 and rotation of the locking mechanism 1050in the opposition direction causes an expansion of the circumferentialassembly 1020. As can be seen in FIGS. 5B and 5C, the keyed block 1075is rotated to cause the guide bullet 1070 to advance towards the keyedblock 1075. FIG. 5C shows the microcylinder locking mechanism 1050 withthe adjustment tool 1060 after adjustment and disengagement of themicrocylinder locking mechanism 1050 by the adjustment tool 1060 with afixed repositioning of the guide bullet 1070 and a distal lengthening ofthe adjustment member 1025 with respect to the microcylinder 1052. Asthe final position of the keyed block 1075 is further away from themicrocylinder 1052, and because the microcylinder 1052 is fixed to thecontrol device 1030 of the circumferential assembly 1020, this exemplarymovement of the adjustment member 1025 indicates that thecircumferential assembly 1020 has reduced in diameter.

Various alternative embodiments of this locking mechanism are envisionedwhere a number of the individual parts are fixed or moving with respectto other ones of the parts of the circumferential assembly 1020, thecontrol device 1030, the locking mechanism 1050, and/or the adjustmenttool 1060. In one alternative embodiment of the microcylinder lockingmechanism 1050, the collar portion 1065 of the remote adjustment tool1060 can contains inner striations (similar to or different from thestriations 1055 of the microcylinder 1052) that allow it to capture andturn the guide bullet 1070 through removable fixation of the tines 1072therein (see FIG. 6E). In such a configuration, the guide bullet 1070can be fixed rotationally to the adjustment member 1025.

The inner striations 1055 of the microcylinder 1052 may be grooves,threads, detents, slots, or other surface features sufficient to allowcapture of the tines 1072 upon their release as shown in further detail,for example, in the cross-sections of FIGS. 6A to 6G. FIG. 6A is across-section along section line A-A of the microcylinder 1052 and guidebullet 1070 of FIG. 5A, in which the tines 1072 having an exemplarytriagonal cross-sectional shape are caught within two striations 1055having an exemplary rectangular cross-sectional shape. FIG. 6B is across-section along section line B-B of the tool sheath 1062 of FIG. 5Aand illustrates the relatively smooth outer surface of the tool sheath1062. FIG. 6C is a cross-section along section line C-C of themicrocylinder 1052 of FIG. 5B without the adjustment member 1025depicted. FIG. 6D is a cross-section along section line D-D of themicrocylinder 1052, the guide bullet 1070, and the tool sheath 1062 ofFIG. 5B, in which the tool sheath 1062 captures the guide bullet 1070and collapses the tines 1072, thereby removing the tines 1072 from thestriations 1055 of the microcylinder 1052.

FIG. 6E shows a cross-sectional view of a variation of another exemplaryembodiment of the locking mechanism 1050′ with the adjustment toolsheath 1062′ also having striations 1055′ with an exemplary rectangularcross-sectional shape. The tines 1072 are illustrated as expanded withintwo opposing striations 1055′ of the tool sheath 1062′. As the toolsheath 1062′ has a smooth exterior, the tool sheath 1062′ can rotatewithout friction within the microcylinder 1052′.

FIGS. 6F and 6G show cross-sectional views of yet another variation ofan exemplary embodiment of the microcylinder locking mechanism 1050″ andadjustment tool 1060″. The locking mechanism 1050″ has a microcylinder1052″ with striations 1055″ having an exemplary triangularcross-sectional shape. The adjustment tool sheath 1062″ has a smoothexterior and interior to slide within the microcylinder 1052″ and toslideably capture the tines 1072′″, respectively. The tines 1072″ areillustrated as expanded within two opposing triangular striations 1055″of the microcylinder 1052″ in FIG. 6F and are captured within the toolsheath 1062″ in FIG. 6G.

FIGS. 7A and 7B show longitudinal cross-sectional details of oneexemplary embodiment of a locking mechanism 1110 for the adjustment tool1035 according to the present invention. FIG. 7A shows a lockingmechanism 1110 comprising a controllable catch 1115 in a disengagedstated. FIG. 6B shows the locking mechanism 1110 with the controllablecatch mechanism 1115 engaged. Once the adjustment member catch 1120 iswithin the target range 1117 of the locking mechanism, the user canengage a non-illustrated catch deployment device to capture theadjustment member catch 1120.

FIGS. 8A to 8C show details of still another embodiment of amicrocylinder locking mechanism 1150 according to the present invention,in which internal locking tines 1152, 1154 of unequal length areemployed to prevent back rotation from torque buildup upon detachment ofthe remote adjustment tool 1060. FIG. 8A shows the locking mechanism1150 comprised of a microcylinder 1151 and a guide bullet 1153 withinternal locking tines 1152, 1154 of unequal length and an associatedadjustment tool 1160 having a tool sheath 1164 prior to engagement ofthe microcylinder locking mechanism 1150 by the tool sheath 1164. FIG.8B shows the tool sheath 1164 of FIG. 8A engaged with the microcylinderlocking mechanism 1150 to deflect the tines 1152, 1154 away from theinterior surface of the microcylinder 1151. FIG. 8C shows themicrocylinder locking mechanism 1150 in a locking position differentfrom FIG. 8A after adjustment has occurred and the tool sheath 1164 hasbeen disengaged from the microcylinder 1151.

FIGS. 9A and 9B show two aspects of details of sheathable retentiontines 1130 and a compressible foam sealing gasket 1140 for the proximalterminal aspect of some exemplary embodiments of endografts according tothe present invention. FIG. 9A is an axial cross section showingsheathable retention tines 1130 sheathed by an expanded compressiblefoam gasket 1040 in an exemplary proximal aspect of a sealable endograftsystem 1000 according to the present invention. FIG. 9B is a perspectiveview showing sheathable retention tines 1130 exposed and deployedthrough the compressible foam sealing gasket 1140 disposed at anexpanded proximal cuff 1010 in an exemplary endograft according to thepresent invention. In some exemplary embodiments of the presentinvention, the direct pressure of the adjustment member 1025 on thefootplate 1145 of the tines may be used to extend the sheathable tines1130 through the compressible foam gasket 1040 and into the wall of arecipient blood vessel. In yet other exemplary embodiments of thepresent invention, direct pressure of the adjustment member 1025 mayexert force on non-illustrated footplate bands that may be attached toor adjacent the footplates 1145 of the tines 1130 and may be used toextend the sheathable tines 1130 through the compressible foam gasket1040 and into the wall of a recipient blood vessel. Such footplate bandsmay, themselves, be the base of the sheathable tines 1130 in certainexemplary embodiments of the present invention. Not shown in FIGS. 9Aand 9B, the adjustment member 1025 may course though eyelets, otherbrackets or may otherwise be movably connected to the footplates 1145 tomaintain equal pressure and desired orientation upon expansion of theadjustment member loop.

In the various embodiments of sealable endograft systems according tothe present invention, the distal attachment of the endograft to theaortic wall distal to the aneurysm sac may be accomplished in aconventional manner using an expandable lattice component at the distalcuffs, or variations on the adjustable, sealable mechanism disclosedherein may be employed to secure distal seals. The distal seals aresubject to lower pressure demands, and the anatomic constraints ofsufficient aortic neck distally are generally less problematic than forthe proximal seal.

FIGS. 10 to 13 provide anatomic views of another exemplary embodiment ofan endograft implant according to the present invention in which theimplant is a universal proximal cuff endovascular implant for treatmentof an abdominal aortic aneurysm. Endografts with the features shown inthe various embodiments of the present invention have unique abilitiesto accommodate to anatomic variations that would preclude or compromiseuse of conventional endograft systems. The universal proximal cuffimplants of the present invention allow an operator to make use of theirability to securely seal and attach in anatomic sites where conventionalendografts cannot be securely placed, and then allow a conventionalendograft to securely dock with the universal proximal cuff endovascularimplants distally.

Universal proximal cuff endovascular implants of the present inventionmay be provided with any of the elements disclosed in the present andthe incorporated co-pending applications referenced herein. Suchelements include, but are not limited to, attachment of radio-opaquemonitoring clip assemblies on the outer surfaces of endografts to allowpost-implantation monitoring of slippage or endoleak formation by plainradiographs, steerable delivery systems to permit delivery and seal ofan endograft in an anatomically angulated or irregular site, and/orauto-accommodation for post-implantation aortic remodeling,

FIG. 10A is an axial cross-sectional view of an exemplary endovascularuniversal interface cuff 1155 of the present invention to be implantedinto an aorta having an aneurysm sac 1170 and an aortic wall 1175. Theuniversal endovascular interface cuff 1155 has been positioned over anendovascular guidewire 1160 to a desired recipient site A-A′ proximal tothe aortic aneurysm sac 1170. The endovascular universal interface cuff1155 further comprises an accommodating proximal cuff 1010 and a rigiddistal cuff 1200. FIG. 10B provides a transverse cross-sectional view ofthe exemplary endovascular interface cuff 1155 of FIG. 10A at the levelof A-A′ in FIG. 10A. In FIGS. 10A and 10B, the compressible foam gasket1140 is uncompressed and, therefore, covers the retention tines 1165.

In the exemplary embodiment shown in FIG. 10B, the adjustment member1025 courses in a circumferential loop through eyelets 1180 attached toa series of compression footplates 1185. The compression footplates1185, among other functions, serve to maintain an orientation of theexpanding circumferential loop 1035 in a plane transverse to the aorticlumen 1190, and present a broader pressure contact with the underlyingaortic wall 1175 when the circumferential assembly is expanded. Thecompression footplates 1185 may abut, be attached to, or be contiguouswith the retention tines 1165, which are displaced through thecompressed compressible foam gasket 1140 and allowed to enter the aorticwall 1175 for overall device stabilization and retention. While fourretention tines 1165 and footplates 1185 are shown, this embodiment ismerely exemplary and can be any number.

FIG. 11A shows the same axial cross-sectional view of the endovascularuniversal interface cuff 1155 of FIG. 10A but after the universalendovascular interface cuff 1155 has expanded to achieve a seal in theaortic wall 1175. Due to the expansion of the cuff, the foam gasket 1140becomes compressed, allowing the retention tines 1165 to protruderadially outward to engage the aortic wall 1175 in the desired recipientsite A-A′ proximal to the aortic aneurysm sac 1170. In the exemplaryembodiment shown in FIG. 11B, the adjustment member 1025 has expanded tomove the eyelets 1180 attached to the footplates 1185 outwards. As isevident, the interior lumen of the circumferential assembly 1020 shownin FIG. 11B has increased substantially as compared to the state shownin FIG. 10B. In FIG. 11B, the compression of the foam gasket 1140 andthe engagement of the aortic wall 1175 by the retention tines 1165creates a firm seal between the universal endovascular interface cuff1155 and the aortic wall 1175.

FIG. 12 shows the same axial cross-sectional axial of the universalendovascular interface cuff 1155 of the present invention as in FIGS.10A and 11A but with delivery of a conventional endograft 1300 into theaortic wall 1175, which endograft 1300 has been secured within the rigiddistal cuff 1200 of the universal endovascular interface cuff 1155. Theendograft 1300 can include an expandable lattice 1310. FIG. 13 shows thesame cross-sectional axial view of an exemplary universal endovascularinterface cuff 1155 of the present invention as FIG. 12 but afterremoval of the endovascular guidewire 1160 and detachment and removal ofthe adjustment member 1025. Such removal and detachment can be carriedout by a release mechanism 1037. The distal attachment of theconventional endograft is not shown in FIGS. 12 and 13, but can beaccomplished in the usual manner for conventional endograft implantationsufficient to prevent backfill of the aneurysm sac 1170 from the distalaorta or the iliac vessels.

As shown in FIGS. 10A, 11A, 12, and 13, the rigid distal cuff 1200includes, at its exterior, exemplary radio-opaque monitoring clipassemblies 1225 to allow post-implantation monitoring of slippage orendoleak formation and/or auto-accommodation for post-implantationaortic remodeling. Likewise, the rigid distal cuff 1200 can be providedwith interior graft retention tines 1227 that add to securing, withoutleaks, the endograft 1300 to the interior of the rigid distal cuff 1200.

The tubular endograft body 1005, the proximal cuff 1010, the rigiddistal cuffs 1200, and the endograft body 1300 as described herein maybe constructed of solid, woven, non-woven, or mesh materials such as,but not limited to, natural or synthetic rubbers, nylon, GORE-TEX®,elastomers, polyisoprenes, polyphosphazenes, polyurethanes, vinylplastisols, acrylic polyesters, polyvinylpyrrolidone-polyurethaneinterpolymers, butadiene rubbers, styrene-butadiene rubbers, rubberlattices, DACRON®, PTFE, malleable metals, other biologically compatiblematerials or a combination of such biologically compatible materials ina molded, woven, or non-woven configuration, coated, non-coated, andother polymers or materials with suitable resilience and pliabilityqualities. In certain exemplary embodiments according to the presentinvention, it is desirable for the non-elastic tubular member 1015 andcorresponding structures to be pliable to allow for folding orcompressibility without allowing elasticity. In certain exemplaryembodiments according to the present invention, it is desirable for theaccommodating proximal cuff 1010 and corresponding structures to haveplasticity and be compressible or foldable. In any given exemplaryembodiment, the non-elastic tubular implant body 1015, the endograftbody 1300, the accommodating proximal cuff 1010, and correspondingstructures may be constructed of the same material of varyingelasticity, or these structures may be constructed of different, butcompatible materials.

The adjustment members 1025, the retention tines 1130, 1165, and themicrocylinders 1030 and other mechanical components as disclosed hereinand in all other embodiments of the present invention may be fabricatedof any suitably strong biocompatible material, including, but notlimited to titanium, stainless steel, cobalt chromium alloys, othermetals, other metal alloys, nitinol, plastics, or ceramics. Similarly,the adjustment members 1025, the retention tines 1130, 1165, and themicrocylinders 1030 and other mechanical components may be milled, lasercut, lathed, molded, or extruded.

The compressible foam gaskets 1140 as disclosed herein may be anybiocompatible foam material of either an open or closed cell structurewith sufficient compressibility and resilience to allow rapid recoveryin a non-compressed state. In various exemplary embodiments according tothe present invention, such foam materials may be viscoelastic foam witha compressible cellular material that has both elastic (spring-like) andviscous (time-dependent) properties. Viscoelastic foam differs fromregular foam by having time-dependent behaviors such as creep, stressrelaxation, and hysteresis.

FIGS. 14A and 14B show an alternate exemplary embodiment of a sealableendograft system 2000 according to the present invention in twodifferent states. In the view of FIG. 14A, a hinged lattice structure2100 is attached to an internal or external surface of at least theproximal portion 2210 of an endograft body 2200 (the “lattice” in thesefigures is only diagrammatic and is not intended to imply that the onlypossible number of rings of lattice is greater than one). Either thelattice structure 2100 or the endograft body 2200 can be provided withradially displaced retention tines 2105 that, in a non-distended stateof the proximal portion 2210, can be covered within a compressible foamgasket 2300. In the embodiment shown in FIG. 14A, the distal portion2220 of the endograft body 2200 comprises a non-distensible material andthe proximal portion 2210 of the endograft body 2200 is an accommodatingcuff comprising a distensible material forming the proximally terminalaspect of the sealable endograft system 2000 and enclosing the terminalhinged lattice structure 2100 therewithin.

A control system 2400 or jack screw shown in FIGS. 14A and 14B isprovided to expand and contract the lattice structure 2100. Inparticular, a torque wire 2410 can be fixed at two points 2420, 2430longitudinally separate from one another on the lattice structure 2100.This torque wire 2410 has exterior threads that correspond to threadedbores of one of the two points 2420, 2430. Accordingly, when the torquewire 2410 is rotated, the two points 2420, 2430 of the lattice eitherapproach one another (to expand the proximal portion 2210) or retreatfrom one another (to contract the proximal portion 2210) this impartsmotion to all contiguously interconnected lattice elements. It ispreferred to have the proximal end point 2430 be bored for rotation butfixed longitudinally. In this case, a smooth-bored collar 2440 is fixedto the wall of the graft 2200, for example, on an interior surfacedistal of the lattice structure 2100. When the adjustment tool 1035 isrotated, the torque wire 2410 correspondingly rotates to expand orcontract the proximal portion 2210 of the endograft 2200. In thismanner, in comparison to self-expanding prior art stent structures(e.g., made of nitinol) passively open to their greatest extent whenrelieved from radially inward compression, the lattice structure of thepresent invention is able to actively open according to the desire ofthe user surgeon implanting the prosthesis. As such, the openingperformed by prior art self-expanding stent structures in endograftprosthesis are referred to herein as “passive opening” or “passiveexpansion”. In contrast thereto, the expansion performed by theinventive controllable, hinged, lattice structure of the presentinvention for the disclosed endograft prostheses is referred to hereinas “active control” or “active expansion” because it can be activelycontrolled in both the expansion and contraction directions according tothe desire of the user. This is further in contrast to expansion ofstent structures using balloon, which case is referred to as “balloonopening” or “balloon expansion” because it occurs only in one direction(expansion) without any ability to contract actively. The singleembodiment of the jack screw shown in FIGS. 14A and 14B can bereplicated any number of times about the circumference of the latticestructure 2100

In a non-illustrated alternative to the configuration of the systemshown in FIG. 14B, the configuration shown in FIGS. 10A to 11B can beincorporated into the system of FIGS. 14A and 14B to create a hybridsystem. The circumferential assembly 1020 can be positioned at theproximal end of the endograft and action of the circumferential loop1035 within the proximal cuff 1010, can be used to expand and contractthe latticework 2100.

FIG. 15A is a lateral view of an exemplary embodiment of an adjustablevascular cannula 1230 according to the present invention. As shown inFIG. 15A, such an adjustable vascular cannula 1230 is a generallytubular structure with external cannula walls 1235 defining a cannulalumen 1240, and comprises a port end 1245, a cannula body 1250, and acannula tip 1255. As further shown in FIG. 15A, the cannula body 1250 isfurther provided with a delivery recess 1260 in its external wallstructure at or near the junction of the cannula tip 1255. Furtherstill, the adjustable vascular cannula 1230 of FIG. 15A comprises anadjustable seal device 1265 attached to an adjustment member 1025 suchas a torque wire that extends beyond the port end 1245 of the adjustablevascular cannula 1230 as shown in FIG. 15B. The adjustment member 1025may course through the cannula lumen 1240, or it may course through anaccessory lumen (not shown in FIGS. 15A or 15B) within the cannula wall1235 substantially parallel to the cannula lumen 1240, or it may courseexternally to the adjustable vascular cannula 1230 as shown partiallywithin and partially outside the lumen 1240 in FIG. 15B. When in anon-deployed state, as shown in FIG. 15B, the adjustable seal device1265 is substantially flush with the outer diameter of the cannula walls1235 within the delivery recess 1260 of the cannula body 1250.

FIG. 15C shows the adjustable seal device 1265 in a deployed state,which is the result of torque applied externally to the adjustmentmember 1025 by a user. As shown in FIG. 15C, the adjustable seal device1265 further comprises a hinged adjustable latticework 1270 covered by asealing cuff 1275 which is constructed of a distensible material. Theadjustment member 1025 terminates, for example, in a circumferentialloop 1035 within the sealing cuff 1275, where it may be further coveredby a compressible foam gasket 1140. The adjustment member 1025 mayfurther pass through a locking mechanism 1050 as disclosed elsewhereherein which serves to regulate the torque applied to thecircumferential loop 1035. The hinged adjustable latticework 1270 mayfurther be provided with one or more retention tines 1130, 1165, whichare radially displaced from the terminal aspect of the hinged adjustablelatticework 1270, and which are enclosed within and covered by thecompressible foam gasket 1140 when the adjustable seal device 1265 isnot distended. When torque is applied to the adjustment member 1025 by auser, the diameter of the circumferential loop 1035 is increased,displacing the hinged adjustable latticework 1270 as shown in FIG. 15Cuntil the compressible foam gasket 1140 and the sealing cuff 1275 isable to firmly engage the inner wall 1190 of a recipient blood vessel1175. A slight additional amount of torque applied to the adjustmentmember 1025 is, then, sufficient to compress the compressible foamgasket 1140 and allow the retention tines 1130, 1165 to engage the wall1190 of the recipient blood vessel 1175, thus preventing slippage of thecannula during use. In various exemplary embodiments of the presentinvention, the retention tines 1130, 1165 may be provided to engage thevessel wall 1190 in a substantially straight manner or at angles varyingfrom about 1 degree to about 179 degrees. The retention tines 1130, 1165may be angled axially or longitudinally in various embodiments accordingto the present invention. After the use of the cannula is completed, thetorque of the adjustment member 1025 may be reversed, collapsing theadjustable seal device 1165, and allowing the compressible foam gasket1140 to re-expand, thus withdrawing the retention tines 1165 from thevessel wall 1175 and covering the retention tines 1165 to allowatraumatic cannula withdrawal.

Although the foregoing embodiments of the present invention have beendescribed in some detail by way of illustration and example for purposesof clarity and understanding, it will be apparent to those skilled inthe art that certain changes and modifications may be practiced withinthe spirit and scope of the present invention. Therefore, thedescription and examples presented herein should not be construed tolimit the scope of the present invention, the features of which are setforth in the appended claims.

The foregoing description and accompanying drawings illustrate theprinciples, exemplary embodiments, and modes of operation of theinvention. However, the invention should not be construed as beinglimited to the particular embodiments discussed above. Additionalvariations of the embodiments discussed above will be appreciated bythose skilled in the art and the above-described embodiments should beregarded as illustrative rather than restrictive. Accordingly, it shouldbe appreciated that variations to those embodiments can be made by thoseskilled in the art without departing from the scope of the invention asdefined by the following claims.

1. A surgical implant, comprising: an implant body; and a selectivelyadjustable assembly attached to the implant body, having adjustableelements, and operable to cause a configuration change in a portion ofthe implant body and, thereby, permit implantation of the implant bodywithin an anatomic orifice to effect a seal therein under normalphysiological conditions.
 2. The surgical implant according to claim 1,wherein: the implant body has a circumferentially expanding cuff; andthe adjustable assembly comprises an adjustment member operable to causeexpansion and contraction of the cuff.
 3. The surgical implant accordingto claim 2, wherein the portion of the implant body is a proximalportion at which the cuff is disposed.
 4. The surgical implant accordingto claim 1, wherein: the portion of the implant body is a proximalportion; and the adjustable elements comprise: circumferentiallyexpanding cuff; and an adjustment member operable to circumferentiallyexpand the cuff and allow precise sealing of at least the proximalportion of the implant body within the anatomic orifice.
 5. The surgicalimplant according to claim 4, wherein the adjustable elements comprise acontrol device operable to guide the adjustment member.
 6. The surgicalimplant according to claim 5, wherein the control device comprises acollar attached to the implant body distal of the cuff.
 7. The surgicalimplant according to claim 6, wherein: the adjustment member hasthreads; the collar has corresponding threads at which the threads ofthe adjustment member interact to effect a change in a circumference ofthe cuff.
 8. The surgical implant according to claim 4, wherein thecircumferentially expanding cuff comprises a lattice operativelyconnected to the adjustment member to circumferentially expand andcontract the lattice.
 9. The surgical implant according to claim 8,wherein the adjustment member comprises a jack screw operativelyconnected to the lattice to circumferentially expand and contract thelattice.
 10. The surgical implant according to claim 8, wherein theadjustment member comprises a plurality of jack screws operativelyconnected to the lattice to circumferentially expand and contract thelattice.
 11. The surgical implant according to claim 8, wherein: thelattice has a pair of adjustment points; and the adjustment member isoperably connected to both of the points to circumferentially expand andcontract the lattice.
 12. The surgical implant according to claim 9,wherein: a first of the pair of points is an intermediate point fixedlongitudinally to the lattice and operatively connected to theadjustment member; and a second of the pair of points is a distal endpoint fixed longitudinally to the lattice and operably connected to theadjustment member to permit free rotation of the adjustment member withrespect to the distal end point.
 13. The surgical implant according toclaim 12, wherein: the adjustment member has exterior threads adjacentthe first of the pair of points; the first of the pair of points hasinterior threads operatively connected to the exterior threads of theadjustment member; and the second of the pair of points has a smoothbore for free rotation of the adjustment member therein.
 14. Thesurgical implant according to claim 1, wherein: the selectivelyadjustable assembly is a circumferential assembly; and the adjustableelements comprise: a circumferential cuff; and a circumferential loop atthe cuff and operable to selectively expand and contract the cuff. 15.The surgical implant according to claim 2, wherein: the implant body hasan outer diameter; and the implant body and the circumferentiallyexpanding cuff are foldable to be placed into a delivery catheter havinga diameter smaller than the outer diameter.
 16. A surgical implant,comprising: an implant body; and a selectively adjustable, activelycontrolled assembly attached to the implant body, the assembly havingadjustable elements and being operable to actively control aconfiguration change in a portion of the implant body repeatably in bothin an expansion direction and a contraction direction to, thereby,permit implantation of the implant body within an anatomic orifice toeffect a seal therein under normal physiological conditions.